BPTF Seeks Changes in Performance Goals, Fee Payment Schedule in GDUFA Renegotiations

FOR IMMEDIATE RELEASE                                                          

Jenny Gaines
Senior Manager, Communications and PR           
(202) 721-4123

WASHINGTON,  D.C. – The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates, today asked the Food and Drug Administration (FDA) to consider several changes to performance goals and the fee payment schedule prior to reauthorization of the Generic Drug User Fee Act (GDUFA). BPTF made its requests during a public meeting in White Oak, MD.

BPTF, representing the domestic Active Pharmaceutical Ingredients (API) industry, was a key stakeholder during the original GDUFA negotiations and continues to address industry concerns as renegotiations move forward.

“In our assessment, GDUFA will continue to benefit the generic pharmaceutical industry and its suppliers,” said Alan W. Nicholls, BPTF Chairman. “We also believe progress made in inspection parity between domestic and foreign facilities is a positive step in progressing the safety and quality of the U.S. drug supply chain. However, there are several aspects of GDUFA that have resulted in unintended consequences.”

Particularly, BPTF is concerned the increase in foreign inspections has been at the expense of domestic inspections. Nicholls said a reduction in U.S. inspections could adversely affect API facilities with the best compliance histories, and half of U.S. manufacturers may not receive inspection within a 3-year cycle, which many foreign countries require of API manufacturers in order to reauthorize finished dosage form drug products containing the API.

To help level the playing field, BPTF asked that FDA consider a fee reduction for small businesses during GDUFA II negotiations. “Because of higher-than-expected facility fees, absence of a waiver or discount for small business has resulted in an unintended barrier to business entry and to the competitiveness of small business entities,” Nicholls said.

In addition, BPTF believes the original baseline cost estimate for GDUFA of $299 million was too high, based on user fee carryover of $277.5 million at the end of Year 2 of the program. Thus, BPTF is asking that user fees under GDUFA II be reduced to better align with actual needs of the agreed program.

Nicholls also shared BPTF’s concerns regarding facility fees while pending approval of drug submissions, excessive user fees for bulk pharmaceutical ingredients, and the facility fee/application fee split ratio.


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